Article 105: The Legal Gateway to Ministerial Instructions

1. Key takeaways

Article 105 of Public Health Law No. 89 of 1981 consists of a single sentence: regulations, instructions, and announcements may be issued to facilitate the implementation of the law. It is the legal source of authority for every ministerial document the Iraqi Ministry of Health issues. From this GRZAN draws a methodological conclusion: in Iraq the object of a company’s compliance management is not one law but a stream of instructions, control rules, and announcements; the law supplies authority, not rules. Anyone who works through the Public Health Law article by article as if it were a compliance checklist will miss the very documents that actually bind them, and will never be able to explain why the accepting window can always demand things the law does not mention.

• Article 105 is a one-sentence empowerment clause and the basis of all MOH ministerial documents.
• Substantive rules are generated, amended, and repealed in ministerial instructions and notices, not in statute.
• Documents carry a three-tier hierarchy: statutes, numbered instructions and rules, and unnumbered notices with short validity windows.
• Documents without a number and date cannot be cited as regulation.

2. Legal basis

The instruments examined in this article, with identifiers, dates, and provisions, are tabulated below.

Source grade. Article 105 and the Public Contracts Instructions No. 1 of 2025: primary, verified from the gazette facsimile, provisions read page by page from the layout, with Arabic quotations to be proofread against the original pages before formal publication. COSQC Instruction No. 4 of 2016: primary, verified at page level from the official PDF. The KIMADIA notice of June 2026: primary, verified from an official-domain PDF.

Excerpts:

• Article 105: regulations, instructions, and announcements may be issued to facilitate the implementation of this law.
• Article 37, sixth paragraph (Instructions): the Council of Ministers, on the recommendation of the economic ministerial council and in cases of extreme necessity, may grant exceptions for some government contracts. This is the legal channel through which Council of Ministers Decision No. 592 of 2026 could authorise the MOH and KIMADIA to accept awards below estimated cost by up to 20 percent.
• Article 41 (Instructions): the Instructions No. 2 of 2014 remain applicable to contracts concluded under them; repealed from the date this instrument takes effect.

3. Expert insights

Insight 1: this is legislation of the externally delegated type. The parent law writes only the authorisation; substantive rules are generated, amended, and repealed inside ministerial documents. In China, the medical device regulation distributes classification, registration, and production and distribution licensing across an administrative regulation and accompanying rules, in a clear hierarchy searchable in one official database. Iraq has no unified official regulatory library; ministerial documents sit scattered across the PDF directories of the MOH, the Ministry of Planning, KIMADIA, and COSQC sites, with some pages login-gated or dead. The compliance workload is therefore distributed entirely differently: in China the difficulty is reading, in Iraq the difficulty is collecting.

Insight 2: refutation of the claim that Iraq has no device regulation, so no compliance is needed. The inference runs backwards. Absence at the statutory level means responsibility falls one hundred percent on ministerial documents, and those are harder to exhaust than a statute: they can be issued at directorate level, without a number, and can be posted in a website PDF directory for as little as 21 days. The real risk is never whether a law exists; it is whether the instruction in your hands is the current version.

Insight 3: the three tiers of documents trade stability against effect in reverse. Tier one is statute (No. 89 of 1981, stable and searchable). Tier two is instructions and control rules (numbered by year and citable, but frequently updated). Tier three is announcements and notices (no independent number, strongly time-bound, often with specific start and end dates). The overwhelming majority of obligations demanded of companies in tendering or customs clearance sit in tier three. GRZAN archives by tier and sets high-frequency review only for tier three.

Insight 4: documents without a number and date cannot be cited as regulation. The typical example is the widely circulated English reprint of the Registration Department’s Drug Registration Regulations. It states clearly that the body responsible for registration is the Registration Department of the Technical Affairs Directorate of the MOH, but the document itself carries no number and no issue date, and is hosted on an overseas industry body’s site. Such a document can evidence the department’s own stated position; it cannot be tagged as article X of Iraqi regulation. The test is simple: a document is citable only if it yields the Arabic full title, number, year, and gazette issue or official URL.

4. Practical recommendations

• GRZAN maintains a ministerial documents ledger for every Iraqi client, with nine fixed fields: Arabic full title, translated title, number and year, issuing body, gazette issue or official URL, effective and expiry dates, addressees, our corresponding obligation, reviewer, and next review date.
• The ledger is tiered; tier three (announcements and notices) is reviewed monthly, tier two (instructions and control rules) quarterly, tier one (statutes) annually. Practical estimate: this review cadence is an internal management arrangement (no official provision found).
• Whenever a new requirement is raised at customs, in tendering, or in a document supplement, obtain on the spot the Arabic title and number of the underlying document and enter it in the ledger the same day; where no number is obtainable, record it in the ledger as administrative practice, no document number.
• Wherever internal client reporting contains the phrase Iraqi regulation provides, check it against the ledger; entries without a matching record are rewritten as according to current Ministry of Health practice.
• Do not delete superseded documents; mark the repeal date and the number of the replacing document and archive them. Historical versions are the only basis for explaining questions such as why a 2014 contract still follows the old instructions (the dual-track transition in Article 41 is the classic case).

5. Verification checklist

• □ In the FAOLEX full text locate Article 105 and verify the Arabic wording and the part of the law in which it sits.
• □ Download the gazette original of the Public Contracts Instructions No. 1 of 2025 from the Ministry of Planning website and confirm the Article 37 sixth paragraph exception channel and the Article 41 transition arrangement.
• □ On the Ministry of Planning government contracts page confirm the Instructions No. 1 (2025) remain current and that the No. 2 (2014) instructions are repealed but continue to apply to contracts concluded under them.
• □ On cosqc.gov.iq/laws/instructions check the current instruction list and whether Instruction No. 4 (2016) has been replaced.
• □ Search the kimadia.gov.iq notices section (including the tenders forms page) month by month for new notices and update the ledger.
• □ Request from the Technical Affairs Directorate a list of instructions currently in force (the directorate site tec-moh.com returned HTTP 500 during this verification; retry needed).
• □ Recheck whether the official documents cited here have been superseded by later instructions or decisions (verification date for this article: 29 October 2026).

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Iraqi market. Our team manages KMOC (Kurdistan) and federal MOH registration procedures, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com